Venous ThromboembolismPhase 2/3NCT05515120
Rivaroxaban Plus Aspirin to Manage Recurrent Venous Thromboembolic Events
A Phase 2/3 study testing Rivaroxaban 20 MG [Xarelto], Aspirin 300mg and Acenocoumarol Oral Tablet in people with Venous Thromboembolism and Anticoagulant-induced Bleeding, run by Instituto Mexicano del Seguro Social at 1 site in Mexico.
Trial summary
Venous thromboembolism affects around 10 million people per year worldwide, however, despite its high incidence, there is no systematic review or randomized trial focused on the treatment of patients with recurrent deep vein thrombosis (DVT) and/or or pulmonary embolism (PE) during anticoagulant treatment. Read more about this study
- Who is it for?
- Ages 18 to 74 years
- Conditions the study is for
- Venous Thromboembolism, Anticoagulant-induced Bleeding, Venous Thromboses
- What is being tested?
- Rivaroxaban 20 MG [Xarelto], Aspirin 300mg and Acenocoumarol Oral Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 58 participants
- Where
- 1 siteMexico
- Study dates
- 3 Jan 2021to 1 Jul 2022
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Objectively proven first episode of venous thromboembolism (upper extremity deep vein thrombosis, proximal lower extremity deep vein thrombosis, or pulmonary embolism).
- Objectively documented recurrent venous thromboembolism (either new or extended upper extremity deep vein thrombosis, proximal lower extremity deep vein thrombosis or pulmonary embolism) while taking systemic anticoagulation medication (Rivaroxaban).
Who cannot join
- Previous hemorrhagic stroke Ischemic stroke in the last 3 months Severe renal impairment (CrCl rates < 30 ml/min) Active liver disease (any etiology) Concomitant use of any antiplatelet (aspirin, clopidogrel, prasugrel, ticagrelor, ticlopidine, etc.) Increased risk of bleeding (congenital or acquired) Uncontrolled SAH Gastrointestinal hemorrhage within the past year Anemia (Hb level < 10 g/dl) or thrombocytopenia (platelet count < 100 × 109/l) Pregnant or lactating women
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Instituto Mexicano Del Seguro Social
Metepec, State of Mexico, 55056
About this study
Official title: Rivaroxaban Plus Aspirin Versus Acenocoumarol to Manage Recurrent Venous Thromboembolic Events Despite Systemic Anticoagulation With Rivaroxaban
Venous thromboembolism affects around 10 million people per year worldwide, however, despite its high incidence, there is no systematic review or randomized trial focused on the treatment of patients with recurrent deep vein thrombosis (DVT) and/or or pulmonary embolism (PE) during anticoagulant treatment. The objective was to compare the use of Rivaroxaban plus Aspirin versus Acenocoumarol in patients with recurrent venous thromboembolism treated with rivaroxaban.
Read the detailed description
Venous thromboembolism has two manifestations, deep vein thrombosis (DVT) and pulmonary embolism (PE), affects around 10 million people per year worldwide, with an annual incidence of 1-2 cases per 1000 population and increases exponentially with age. [1,2,3] DVT is a multicausal disease thought to be triggered by interactions between multiple triggering factors that may be additive or synergistic, such as active cancer, antiphospholipid syndrome (APS), or other chronic inflammatory disorders. [2,4] The contribution of genetics to the risk of thromboembolism venous traditionally includes protein C, protein S, and antithrombin deficiencies, prothrombin gene mutation, and factor V Leiden. [5] The exact epidemiology in Mexico is unknown, however, the estimated prevalence of deficiencies in a population studied in Mexico City were Protein C (PC) 0.65%, Protein S (PS) 0.65%, Antithrombin (AT) 2.04% and Plasminogen ( Plg) 2.5%. [6] For the treatment of patients with DVT and/or PE, the American Society of Hematology (ASH) guideline panel suggests using direct oral anticuagulants (DOACs) over vitamin K antagonists (VKAs), [7] however the use of a DOAC instead of a VKA for patients with DVT does not impact mortality, the use of DOACs has also been related to a reduction in the risk of DVT and major bleeding, although this was not statistically significant, the greatest advantage is that the use of DOACs do not require frequent dose adjustment, monitoring of the INR, or dietary restrictions, [8 -31] in our work center we started with DOACs as the first line of treatment.
Recurrent DVT despite anticoagulation has been related to the presence of active cancer, subtherapeutic anticoagulation, use of concomitant anticancer drugs, younger age at presentation (<65 years), and PE as the initial DVT. [32-40] Insertion of an inferior vena cava (IVC) filter was previously recommended in patients with recurrent DVT while receiving anticoagulant therapy. [41] However, the risk of recurrent DVT after IVC filter insertion is as high as 32% in cancer patients and has been associated with significant morbidity and poor quality of life; [42-46] It has been suggested that increasing the dose of low molecular weight heparin (LMWH) may be an alternative to IVC filter insertion in patients with recurrent DVT, [47-49] however, to date, there is no systematic review or randomized trial focused on the treatment of patients with recurrent DVT and/or PE during anticoagulant treatment.
The aim of the current study was to compare the use of Rivaroxaban plus Aspirin versus Acenocoumarol in the prevention of thromboembolic and bleeding events in patients with recurrent venous thromboembolism treated with rivaroxaban.
- Conditions
- Venous Thromboembolism, Anticoagulant-induced Bleeding, Venous Thromboses, Pulmonary Embolism
- Being tested
- Rivaroxaban 20 MG [Xarelto], Aspirin 300mg, Acenocoumarol Oral Tablet
- Keywords
- venous thromboembolism, Rivaroxaban, Aspirin, Acenocoumarol
- Medical subject headings
- Venous Thromboembolism, Venous Thrombosis, Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rivaroxaban 20 MG [Xarelto]Drug
Also called Xarelto 20 mg
It was adopted an equal allocation of patients to each treatment (i.e., 1:1 randomization)
Aspirin 300mgDrug
Also called Acetilsalicilic acid
It was adopted an equal allocation of patients to each treatment (i.e., 1:1 randomization)
Acenocoumarol Oral TabletDrug
Also called Vitamin K antagonist
It was adopted an equal allocation of patients to each treatment (i.e., 1:1 randomization)
| Study group | Role | What they receive |
|---|---|---|
| Rivaroxaban plus Aspirin | Active comparator | Drug: Rivaroxaban 15 mg Rivaroxaban 15 mg BID
Other Names:
Xarelto 15 mg Rivaroxabana 15 mg Drug: Aspirin 300 mg Receives: Drug: Rivaroxaban 20 MG [Xarelto]; Drug: Aspirin 300mg |
| Acenocoumarol | Placebo comparator | Drug: Acenocoumarol Other Name: Vitamin K antagonist Receives: Drug: Acenocoumarol Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy outcome The presence of thromboembolic events
Recurrent ipsilateral Deep vein thrombosis, Recurrent contralateral Deep vein thrombosis, Pulmonary emboli, Ischemic stroke and Myocardial infarction
Measured: 90 days
Secondary outcomes (1)
Major or clinically relevant nonmajor bleeding
The primary safety outcome was major or clinically relevant nonmajor bleeding according to the International Society on Thrombosis and Haemostasis (ISTH) criteria and Bleeding Academic Research Consortium (BARC)
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2022
- Study start3 Jan 2021
- Primary completion9 Jan 2022
- Study completion1 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous ThromboembolismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- It was adopted an equal allocation of patients to each treatment (i.e., 1:1 randomization)
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Mexicano del Seguro Social
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Maximiliano Victor Manuel Correa Lara, Instituto Mexicano del Seguro Social
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05515120
- Sponsor's protocol ID
- 000001
- Status last verified
- Aug 2022
- First submitted
- 18 Aug 2022
- Last updated
- 25 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rivaroxaban Plus Aspirin Versus Acenocoumarol to Manage Recurrent Venous Thromboembolic Events Despite Systemic Anticoagulation With Rivaroxaban
- ClinicalTrials.gov ID
- NCT05515120
- Acronym / sponsor ID
- 000001
- Conditions
- Venous Thromboembolism, Anticoagulant-induced Bleeding, Venous Thromboses, Pulmonary Embolism
- Keywords
- venous thromboembolism, Rivaroxaban, Aspirin, Acenocoumarol
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Instituto Mexicano del Seguro SocialOther government
- Study start
- 3 Jan 2021 (actual)
- Primary completion
- 9 Jan 2022 (actual)
- Study completion
- 1 Jul 2022 (actual)
- First posted
- 25 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Venous thromboembolism affects around 10 million people per year worldwide, however, despite its high incidence, there is no systematic review or randomized trial focused on the treatment of patients with recurrent deep vein thrombosis (DVT) and/or or pulmonary embolism (PE) during anticoagulant treatment. The objective was to compare the use of Rivaroxaban plus Aspirin versus Acenocoumarol in patients with recurrent venous thromboembolism treated with rivaroxaban.
Detailed description
Venous thromboembolism has two manifestations, deep vein thrombosis (DVT) and pulmonary embolism (PE), affects around 10 million people per year worldwide, with an annual incidence of 1-2 cases per 1000 population and increases exponentially with age. [1,2,3] DVT is a multicausal disease thought to be triggered by interactions between multiple triggering factors that may be additive or synergistic, such as active cancer, antiphospholipid syndrome (APS), or other chronic inflammatory disorders. [2,4] The contribution of genetics to the risk of thromboembolism venous traditionally includes protein C, protein S, and antithrombin deficiencies, prothrombin gene mutation, and factor V Leiden. [5] The exact epidemiology in Mexico is unknown, however, the estimated prevalence of deficiencies in a population studied in Mexico City were Protein C (PC) 0.65%, Protein S (PS) 0.65%, Antithrombin (AT) 2.04% and Plasminogen ( Plg) 2.5%. [6] For the treatment of patients with DVT and/or PE, the American Society of Hematology (ASH) guideline panel suggests using direct oral anticuagulants (DOACs) over vitamin K antagonists (VKAs), [7] however the use of a DOAC instead of a VKA for patients with DVT does not impact mortality, the use of DOACs has also been related to a reduction in the risk of DVT and major bleeding, although this was not statistically significant, the greatest advantage is that the use of DOACs do not require frequent dose adjustment, monitoring of the INR, or dietary restrictions, [8 -31] in our work center we started with DOACs as the first line of treatment.
Recurrent DVT despite anticoagulation has been related to the presence of active cancer, subtherapeutic anticoagulation, use of concomitant anticancer drugs, younger age at presentation (<65 years), and PE as the initial DVT. [32-40] Insertion of an inferior vena cava (IVC) filter was previously recommended in patients with recurrent DVT while receiving anticoagulant therapy. [41] However, the risk of recurrent DVT after IVC filter insertion is as high as 32% in cancer patients and has been associated with significant morbidity and poor quality of life; [42-46] It has been suggested that increasing the dose of low molecular weight heparin (LMWH) may be an alternative to IVC filter insertion in patients with recurrent DVT, [47-49] however, to date, there is no systematic review or randomized trial focused on the treatment of patients with recurrent DVT and/or PE during anticoagulant treatment.
The aim of the current study was to compare the use of Rivaroxaban plus Aspirin versus Acenocoumarol in the prevention of thromboembolic and bleeding events in patients with recurrent venous thromboembolism treated with rivaroxaban.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- It was adopted an equal allocation of patients to each treatment (i.e., 1:1 randomization)
| Arm | Type | Receives |
|---|---|---|
| Rivaroxaban plus Aspirin | Active comparator | Drug: Rivaroxaban 20 MG [Xarelto], Drug: Aspirin 300mgDrug: Rivaroxaban 15 mg Rivaroxaban 15 mg BID Other Names: Xarelto 15 mg Rivaroxabana 15 mg Drug: Aspirin 300 mg |
| Acenocoumarol | Placebo comparator | Drug: Acenocoumarol Oral TabletDrug: Acenocoumarol Other Name: Vitamin K antagonist |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Objectively proven first episode of venous thromboembolism (upper extremity deep vein thrombosis, proximal lower extremity deep vein thrombosis, or pulmonary embolism).
- Objectively documented recurrent venous thromboembolism (either new or extended upper extremity deep vein thrombosis, proximal lower extremity deep vein thrombosis or pulmonary embolism) while taking systemic anticoagulation medication (Rivaroxaban).
Key exclusion criteria (1 listed)
- Previous hemorrhagic stroke Ischemic stroke in the last 3 months Severe renal impairment (CrCl rates < 30 ml/min) Active liver disease (any etiology) Concomitant use of any antiplatelet (aspirin, clopidogrel, prasugrel, ticagrelor, ticlopidine, etc.) Increased risk of bleeding (congenital or acquired) Uncontrolled SAH Gastrointestinal hemorrhage within the past year Anemia (Hb level < 10 g/dl) or thrombocytopenia (platelet count < 100 × 109/l) Pregnant or lactating women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rivaroxaban 20 MG [Xarelto]Also: Xarelto 20 mgIt was adopted an equal allocation of patients to each treatment (i.e., 1:1 randomization) | Drug | Rivaroxaban plus Aspirin |
| Aspirin 300mgAlso: Acetilsalicilic acidIt was adopted an equal allocation of patients to each treatment (i.e., 1:1 randomization) | Drug | Rivaroxaban plus Aspirin |
| Acenocoumarol Oral TabletAlso: Vitamin K antagonistIt was adopted an equal allocation of patients to each treatment (i.e., 1:1 randomization) | Drug | Acenocoumarol |
Primary outcome
Efficacy outcome The presence of thromboembolic events
Time frame: 90 days
Recurrent ipsilateral Deep vein thrombosis, Recurrent contralateral Deep vein thrombosis, Pulmonary emboli, Ischemic stroke and Myocardial infarction
1 secondary outcome
Major or clinically relevant nonmajor bleeding
Time frame: 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Rivaroxaban 20 MG [Xarelto], Aspirin 300mg and Acenocoumarol Oral Tablet in people with Venous Thromboembolism and Anticoagulant-induced Bleeding, run by Instituto Mexicano del Seguro Social at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy outcome The presence of thromboembolic events (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2022.